AEYE-DS Clinical Trials Published: First Fully Autonomous Diabetic Retinopathy Screening Technology Across Portable and Tabletop Devices Demonstrates 99% Imageability, One-Image-per-Eye Workflow, and Best-in-Class Diagnostic Efficacy

The pivotal trial results prove AEYE Health's FDA-cleared AI achieves >99% imageability and unmatched diagnostic accuracy using just a single image per eye, with both portable and tabletop devices, powering the industry's first practical fully autonomous diabetic eye exam screening technology.

NEW YORK, Sept. 9, 2026 /PRNewswire/ -- AEYE Health, the leader in ophthalmic AI and retinal diagnostics and the developer of AEYE-DS, today announced the peer-reviewed publication of its prospective, controlled pivotal trials results in Frontiers in Digital Health. The landmark paper, titled "Autonomous AI-driven point-of-care screening for diabetic retinopathy compared to reading center multi-expert clinical review: results from three prospective controlled pivotal validation studies with AEYE-DS in over 1,200 patients," reveals the multi-center clinical validation trials that earned the company its groundbreaking U.S. Food and Drug Administration (FDA) approvals.

AEYE-DS is an FDA-cleared fully autonomous AI solution for diabetic retinopathy, eliminating the need for physician interpretation. Compatible with both handheld and tabletop cameras, it stands as the only portable solution on the market and the only solution to require just a single image per eye. The solution features over 99% gradeability ("imageability") of patients to be screened, ensuring exceptional practicality in real-world clinical settings, with rare need for dilation.

The newly published research details the prospective multi-center clinical trials' validation results across three trials (AEYE-1, AEYE-2, and AEYE-3) involving over 1,200 patients with diabetes, establishing the rigorous clinical foundation that earned AEYE-DS its two approvals from the FDA.

Diabetic retinopathy remains the leading cause of preventable blindness in working-age adults in the US. Despite clinical guidelines recommending annual eye exams, over 60% of patients skip screenings due to accessibility barriers and specialist shortages. The peer-reviewed publication highlights how AEYE-DS eliminates these barriers by bringing AI diabetic eye exams directly to the point of care:

• First & Only Portable Autonomous AI: Validated diagnostic performance using both portable handheld and tabletop cameras, making AEYE Health the market's only solution offering an FDA-cleared portable handheld option.
• Single-Image & Non-Dilated Efficiency: As the only solution requiring just one image per eye for the analysis, AEYE-DS significantly reduces screening time, complexity, and improves patient comfort.
• Groundbreaking Diagnostic Accuracy: Demonstrated outstanding sensitivity (92%-93% for the portable solution, 93% for tabletop) and specificity (89%-94% for the portable solution, 91.4% for tabletop) for detecting more-than-mild diabetic retinopathy (mtmDR). 
• 100% Sensitivity for Severe Cases: Achieved a 100% sensitivity rate for ETDRS ≥ 43, including all severe diabetic retinopathy cases across all 3 clinical trials, ensuring critical high-risk cases are never missed.
• >99% Imageability: AEYE-DS successfully analyzed >99% of patient images across all 3 clinical trials, delivering instant diagnostic results and virtually eliminating ungradable image rejections.
• 99% Intra-Operator Repeatability: Proven reliable when operated by general clinic staff rather than eye care specialists, ensuring seamless integration into daily primary care workflows.

"The data from AEYE-DS's three clinical trials speak for themselves. AEYE-DS finally makes diabetic eye exams practical at the point of care: portable and tabletop devices, just one image per eye, no dilation, and best-in-class diagnostic efficacy. No other FDA-cleared solution does any of that," said Dr. Zack Dvey-Aharon, Ph.D., Co-Founder and CEO of AEYE Health. "With this groundbreaking clinical evidence, a screening workflow that can be completed by staff members in just one minute, and seamless EHR integration, we expect AEYE-DS to continue its rapid expansion across the United States and become the new American standard for diabetic eye exams."

About AEYE Health
AEYE Health is a digital health company delivering fully autonomous AI-based diagnostic screening solutions for retinal imaging, with best-in-class clinical results and superior usability. Its diabetic retinopathy screening solution, AEYE-DS, is the fastest growing solution in the US for diabetic eye exams. The company aims to make diagnostic screening practical, accurate, and accessible. AEYE Health enables point-of-care screening for diabetic retinopathy, helping ensure that patients with diabetes are screened regularly. AEYE-DS is the only FDA-cleared autonomous AI for diabetic retinopathy that requires just 1 image per eye and the only approved AI for a portable camera. A pioneer and leader in Oculomics, AEYE Health's AEYE-X is a comprehensive health assessment platform that screens for more than 100 indications, making it the industry's broadest and most advanced Oculomics platform.

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SOURCE AEYE Health